CLINICAL TRIALS PROFILE FOR EPIVIR

505(b)(2) Clinical Trials for Epivir

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

All Clinical Trials for Epivir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002168 ↗	A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients	Completed	Bristol-Myers Squibb	N/A	1969-12-31	The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
NCT00002183 ↗	A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection	Completed	Glaxo Wellcome	Phase 1	1969-12-31	To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV infection as measured by the development of clinical adverse experiences and laboratory test abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to Retrovir/Epivir or to 1592U89/Retrovir/Epivir.
NCT00002195 ↗	A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 3	1969-12-31	The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.

Clinical Trial Conditions for Epivir

Condition Name

Condition Name for Epivir
Intervention	Trials
HIV Infections	26
HIV	4
HIV-1 Infection	4

Condition MeSH

Condition MeSH for Epivir
Intervention	Trials
HIV Infections	31
Acquired Immunodeficiency Syndrome	8
Infections	7

Clinical Trial Locations for Epivir

Trials by Country

Trials by Country for Epivir
Location	Trials
United States	118
India	7
Korea, Republic of	7
Spain	7
Thailand	6

Trials by US State

Trials by US State for Epivir
Location	Trials
New York	12
California	11
Texas	8
Illinois	7
Massachusetts	6

Clinical Trial Progress for Epivir

Clinical Trial Phase

Clinical Trial Phase for Epivir
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Epivir
Clinical Trial Phase	Trials
Completed	36
Unknown status	4
Withdrawn	2

Clinical Trial Sponsors for Epivir

Sponsor Name

Sponsor Name for Epivir
Sponsor	Trials
Glaxo Wellcome	8
National Institute of Allergy and Infectious Diseases (NIAID)	8
Bristol-Myers Squibb	5

Sponsor Type

Sponsor Type for Epivir
Sponsor	Trials
Other	37
Industry	27
NIH	17

Epivir: Clinical Trials, Market Analysis, and Projections

Introduction to Epivir

Epivir, also known by its generic name lamivudine, is an antiretroviral medication used in the treatment of HIV-1 infection and hepatitis B. It belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs) and works by inhibiting the replication of the virus.

Clinical Trials and Efficacy

Historical Clinical Trials

Epivir has been extensively studied in various clinical trials to evaluate its efficacy and safety. Here are some key findings:

• Combination Therapy: Studies have shown that combinations including Epivir are more effective than comparator medicines. For instance, when Epivir was combined with zidovudine, it increased CD4 cell counts and reduced viral loads more effectively than the comparator medicines after 24 weeks of treatment[4].
• Pediatric Studies: Epivir has also been studied in pediatric patients aged between nine months and 15 years. These studies compared the effects of Epivir taken with zidovudine to didanosine taken alone and found that the combination of Epivir and zidovudine was more effective in maintaining the health of these patients[4].

Current and Ongoing Trials

While Epivir itself is not in the phase of new clinical trials as it is an established drug, its use in combination with other antiretrovirals continues to be evaluated in various studies. For example, the evolution of HIV treatment regimens often involves combining Epivir with newer drugs to optimize treatment outcomes.

Market Analysis

Current Market Size and Trends

The global HIV drugs market, which includes Epivir, was valued at USD 34.57 billion in 2023. This market is expected to grow significantly, reaching USD 77.6 billion by 2032, with a CAGR of 9.4% during the forecast period (2025-2032)[5].

Regional Market Performance

• North America: This region is expected to remain a leading market for HIV drugs, including Epivir, due to the high incidence of HIV infections in countries such as the United States and Canada[5].
• Europe and Other Regions: Europe, Asia Pacific, Latin America, and the Middle East & Africa are also significant markets, with varying growth rates driven by factors such as awareness programs, accessibility of drugs, and the incidence of HIV infections.

Drivers and Barriers

Drivers

• Growing Incidence of HIV: The increasing number of HIV infections globally is a major driver for the market growth of HIV drugs, including Epivir[5].
• New Awareness and Accessibility Programs: Initiatives aimed at increasing awareness and accessibility of HIV drugs are expected to drive market development[5].

Barriers

• Risk of Side Effects and Toxicity: The risk of side effects and toxicity associated with HIV drugs can impede sales and market growth[5].
• Drug Resistance: The development of drug resistance is another significant barrier that affects the efficacy and market performance of HIV drugs like Epivir.

Market Projections

Forecast Period

The HIV drugs market, including Epivir, is projected to grow substantially over the next decade. Here are some key projections:

• Market Size: The market is expected to grow from USD 37.82 billion in 2024 to USD 77.6 billion by 2032, with a CAGR of 9.4% during the forecast period (2025-2032)[5].
• Regional Growth: North America is expected to remain a dominant market, while other regions such as Asia Pacific and Latin America will also experience significant growth driven by increasing incidence rates and improving healthcare infrastructure[5].

Emerging Trends

• Integration of Digital Health: The use of digital health technologies is expected to offer lucrative opportunities for HIV drug providers, including those offering Epivir, by improving treatment adherence and patient outcomes[5].
• Dual Therapy: The trend towards dual therapy, where two drugs are used in combination, is also expected to drive market growth as it offers simpler and more effective treatment regimens for patients[5].

Conclusion

Epivir remains a crucial component in the treatment of HIV-1 infection, with a strong track record of efficacy and safety established through numerous clinical trials. The market for HIV drugs, including Epivir, is poised for significant growth driven by increasing incidence rates, new awareness programs, and advancements in treatment regimens.

Key Takeaways

• Established Efficacy: Epivir has been proven effective in combination with other antiretrovirals in reducing viral loads and increasing CD4 cell counts.
• Market Growth: The global HIV drugs market is expected to grow from USD 37.82 billion in 2024 to USD 77.6 billion by 2032.
• Regional Performance: North America will remain a leading market, while other regions will also experience growth.
• Emerging Trends: Integration of digital health and dual therapy are expected to drive market growth.

FAQs

What is Epivir used for?

Epivir, or lamivudine, is used in the treatment of HIV-1 infection and hepatitis B. It is an antiretroviral medication that belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs).

What were the key findings from clinical trials of Epivir?

Clinical trials have shown that combinations including Epivir are more effective than comparator medicines in increasing CD4 cell counts and reducing viral loads. It has also been effective in pediatric patients when combined with zidovudine[4].

What is the projected market size for HIV drugs by 2032?

The global HIV drugs market, including Epivir, is projected to reach USD 77.6 billion by 2032, growing at a CAGR of 9.4% during the forecast period (2025-2032)[5].

What are the main drivers for the growth of the HIV drugs market?

The main drivers include the growing incidence of HIV infections, new awareness and accessibility programs, and the integration of digital health technologies[5].

What are the potential barriers to the growth of the HIV drugs market?

The risk of side effects and toxicity, as well as the development of drug resistance, are significant barriers that can impede market growth[5].

How does the regional market performance vary for HIV drugs?

North America is expected to remain the leading market, while other regions such as Asia Pacific and Latin America will also experience significant growth driven by increasing incidence rates and improving healthcare infrastructure[5].

Sources

1. Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection. Merck.
2. Global Drug Forecast and Market Analysis to 2025 - GlobalData.
3. HIV Clinical Trials Market Size, Share | Industry Report, 2030. Grand View Research.
4. Epivir | European Medicines Agency (EMA).
5. HIV Drugs Market Growth, Size & Share Analysis | 2032. SkyQuest.

Last updated: 2025-01-01